Sr System Engineer- MSAT Systems

Build the analytics backbone that powers smarter manufacturing. As FUJIFILM Biotechnologies' Senior System Engineer — MSAT Applications, you will own and evolve the platforms that let our Manufacturing Science & Technology (MSAT) teams see, understand, and control processes in real time.

From SIMCA-online and TIBCO Statistica to PAT and historian integrations, you’ll make sure these GxP systems are secure, validated, reliable, and fast—so scientists and engineers can make data-driven decisions that improve yield, reduce deviations, and speed life‑changing therapies to patients.

Turn data into decisions:
Your work enables robust multivariate monitoring and real‑time analytics that drive right‑first‑time performance and continuous improvement.

Protect our license to operate:
You’ll embed cGxP, data integrity (ALCOA+), and validation into mission‑critical systems—strengthening audit and inspection outcomes.

Scale impact across sites:
By standardizing and integrating MSAT tools across manufacturing and development, you’ll uplift reliability and insight network‑wide.

Administer and support SIMCA-online, Statistica Server, and PAT platforms.

Manage Windows Server instances, services, and dependencies; ensure uptime and capacity planning.

Maintain databases (SQL Server/Oracle) for configuration, results storage, and audit trails.

Integrate with DCS/SCADA (e.g., DeltaV), historians (e.g., OSIsoft PI/AVEVA), MES (e.g., Syncade), LIMS/ELN, OPC UA/DA/MQTT gateways, and file/API‑based exchanges.

Manage data retention, archival, and restoration aligned to corporate data governance policies.

Ensure cGxP, ALCOA+, and security requirements across integrations; partner with QA/CSV on risk‑based validation (GAMP5,CSA) and audit readiness.

Implement RBAC/least‑privilege, AD/LDAP integration, and SSO where applicable.

Manage audit trails, e‑signatures, certificates, and secure configurations.

Coordinate vulnerability management, patching, and endpoint protection aligned with GxP and downtime windows.

Provide tiered support; run incident/problem/change management with root‑cause analysis and CAPA.

Monitor system health, job queues, connectors, and data flows; tune performance and troubleshoot latency.

Coordinate vendor relationships, licenses, and support contracts; plan upgrades and patch cycles.

Implement business continuity, backup/restore validation, and disaster recovery testing.

Configure systems to meet evolving business requirements.

Prepare and support internal/external audits and health authority inspections.

Maintain complete, contemporaneous records of configurations, deviations, and changes.

And other job duties that may be assigned from time to time.

• Bachelor’s degree in Computer Science, IT, Engineering, or a scientific field.
• 8+ years of relevant experience in Information Technology or Engineering.
• 3+ years’ experience with MSAT‑type applications (e.g., SIMCA‑online, Statistica, synTQ, Aspen Tech) or historian applications.

• Experience in manufacturing or process development systems.
• Strong Windows Server/Active Directory administration; scripting (Power Shell); SQL Server/Oracle fundamentals.
• Experience with OSIsoft PI/AVEVA, OPCUA/DA, and DCS/SCADA or MES integrations.
• Proven change/incident/problem management using ITIL practices.

• Fluency in manufacturing data flows and MSAT use cases; ability to translate requirements into robust configurations.
• Hands‑on validation expertise and documentation rigor (CSV mindset) with an eye for…